The most common ways of delivering a therapeutically active compound to a patient include oral delivery of liquid compositions, intravenous delivery of injectable compositions, oral delivery of tablets and topical application of solid or liquid compositions. Each of these administration methods has its advantages and it drawbacks. Recently, solid matrices containing therapeutically active compounds have been used to buccally (i.e., orally) deliver therapeutically active compounds to patients.
One of the primary benefits of buccal delivery devices relates to the rapid systemic delivery of therapeutically active compounds delivered transmucosally. As such, these devices are particularly useful as premedication before anesthesia, before a painful diagnostic procedure, for emergency room pain management, for post-operative pain control, and other similar application.
The use of buccal delivery of solid matrices has several additional advantages over some of the commonly used administration methods. For example, a solid matrix cannot be spilled. Certain patients may have difficulty administering liquid compositions without spillage. For example, children, the elderly, patients with impaired motor skills or patients who have become weak or emaciated can be prone to spill liquids. Thus, using a liquid administration method is preferably avoided with such patients. This is particularly true when the patient is not monitored during administration by medical staff, but is left to self-administer the liquid containing the therapeutically active compound.
In addition to problems with spillage, other patients are afraid of, or dislike, injections, or have difficulty swallowing tablets. The use of a solid matrix which incorporates a therapeutically active compound circumvents these problems. Moreover, a solid matrix can be placed on the end of a stick or shaft, thus providing a handle to facilitate buccal administration. Both children and adults frequently find this method of administration less intrusive than swallowing tablets or receiving injections.
While the use of a solid matrix may be the preferred method for administering a therapeutically active compound to certain patients, the solid medicated matrix must be packaged so that the matrix is not degraded or contaminated by the environment and so that the solid matrix has a reasonable shelf-life. In addition, the packaging should also be inexpensive and easy to open.
U.S. Ser. No. 07/776,543, filed Oct. 11, 1991, now U.S. Pat. 5,296,234, which is hereby incorporated by reference, describes a stick-like holder and packaging for a pleasant-tasting, hardened medicated matrix. The matrix can be sucrose based, and contain a dosage of medication, such as fentanyl citrate, to provide a noninvasive means for achieving analgesia, sedation and relief from anxiety through transmuscosal absorption. The invention disclosed therein comprises an overcap that covers the portion of the holder on which medicated matrix is positioned, but does not encompass the entire holder. Because the overcap does not encompass the entire holder, the holder and overcap described in the above-referenced application must be packaged by sealing the entire holder and overcap assembly in a foil or laminated plastic pouch. This necessary packaging adds additional steps in the manufacture of the product and increases the product's cost.